MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Codes	Pacing Problem (1439); Pressure Problem (3012); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) a ccu rn called into the emergency support program line for assistance with augmentation on a cardiosave during use.(b)(6) stated that the augmentation was lower than the unassisted systolic pressures.Esp personnel explained that recommendations for augmentation are greater than assisted systolic pressures.At that time matthew the cardiac educator for the facility also joined the call and had questions about possible timing errors.Esp personnel reviewed all the settings the pump was currently in as well as the most recent chest x ray for placement verification.The ecg had artifact and a heart rate of 62.In one to two the arterial waveform was via fiber optic and showed some whip present with assisted pressures of 119 over 48 mean 89 unassisted pressures of 140 over 56 mean 89 and an augmentation of 129.Inflation appeared to be early.In one to one the pressures were 106 over 43 mean 82 and the augmentation was 111.The chest x ray impression stated that the iabp appeared well positioned.The chest x ray image showed the distal radiopaque marker to be in the fourth intercostal space.Troubleshooting included replacing the electrodes for optimal placement flushing the inner lumen in standby and moving the pressure bag and transducer from the pump pole to an independent pole comparing the fiber optic and transducer pressures and comparing the timing and augmentation in pressure trigger.Optimal therapy was being delivered in auto mode using ecg trigger.Esp personnel encouraged matthew to notify the provider of the potential placement concern and to call back for additional troubleshooting if needed.Esp personnel and matthew discussed in detail the causes of catheter whip and how it can affect timing.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24939352
• Report Number: 2248146-2026-0000926
• Device Sequence Number: 13424962
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000490853(17)280715(11)250715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000490853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP
• Patient Sex: Male
• Patient Weight: 75 KG